Quality of Life in Patients With Rectal Cancer Receiving Total Mesorectal Excision With or Without Stoma

Quality of Life in Patients With Rectal Cancer Receiving Neoadjuvant Chemotherapy, Total Mesorectal Excision With or Without Stoma and Adjuvant Chemotherapy: a Prospective, Single-centre Pilot-study

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03487484

Enrollment

Registered

2018-04-04

Start date

2018-03-22

Completion date

2020-03-22

Last updated

2020-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Brief summary

The goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with total mesorectal excision (TME) and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer.

Detailed description

In most cases it is recommended that patients after low anterior resection with TME and neoadjuvant chemoradiotherapy for rectal cancer need a temporarily diverting stoma. Recent evidence suggests that this is not always necessary. The decision for or against a stoma is made by the surgeon in charge and is based on an algorithm of risk factors for anastomotic leakage. Many patients receive an adjuvant chemotherapy postoperative. This may influence the quality of life e.a. due to mucositis and urge incontinency or the stoma itself.The objective of this pilot study is to establish the basis for a randomized controlled trial. The long-term goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with TME and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer. All patients scheduled for low anterior resection of the rectum for rectal carcinoma will be invited to participate and prospectively enrolled into the study.

Interventions

BEHAVIORALQuality of Life Questionnaire for gastrointestinal tract

To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied

BEHAVIORALQuality of Life Questionnaire

To assess quality of life, the SF-36 questionnaire will be applied

BEHAVIORALFaecal Incontinence Score

To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* age older than 18, * low anterior resection and TME due to rectum carcinoma after standardized neoadjuvant combined chemo- and radiotherapy and receiving adjuvant postoperative chemotherapy, * German speaking patient who is capable to fill in the questionnaire, * signed informed consent

Exclusion criteria

* age younger than 18, * preoperative stoma, * not German speaking * inability to fill in the questionnaire, * no standardized chemo- and radiotherapy

Design outcomes

Primary

Measure	Time frame	Description
Change in quality of life specific for the gastrointestinal tract	at Baseline and up to 12 months after surgery	GIQLI Score

Secondary

Measure	Time frame	Description
Change in quality of life	at Baseline and up to 12 months after surgery	Short Form (SF) 36
Change in faecal Incontinence	at Baseline and up to 12 months after surgery	Vaizey Wexner Score

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026